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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Event Detail

Event ID 62578
Product Type Devices
Status Ongoing
Recalling Firm Biomet 3i, LLC
City Palm Beach Gardens
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-31
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution-Distributed in the USA and the countries to Spain, France, Germany, Switzerland, and Australia.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cylinder***Cylinder; Cylindre; Zylinder; Cilindro; Cilindro; Cilindro***RX only***NON STERILE***Caution: Law prohibits dispensing without prescription***Consult instructions for use*** Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast. Lots: 2010100001, 2010080684, and 2010090191 Class II Biomet 3i conducted a recall on the device Low Profile Abutment, Non-Hexed Castable Cylinder due to some packages labeled LPCCC1, Hexed Castable Cylinder possibly containing LPCCC2, Non-Hexed Castable Cylinders. 611 units Z-2271-2012